Sexual Distress Research Articles

Immunohistochemical staining with CD117 and PGP9.5 of excised vestibular tissue from patients with neuroproliferative vestibulodynia.

Neuroproliferative vestibulodynia (NPV), a provoked genital pain characterized by severe allodynia and hyperalgesia, is confirmed in excised vestibular tissue by immunohistochemical staining (>8 CD117-positive immunostained cells/100× microscopic field) rather than by hematoxylin and eosin staining. In this study we sought to assess immunostaining of tissue samples obtained during vestibulectomy surgery and to correlate results with patient outcomes. Patients (n = 65) meeting criteria for NPV who underwent vestibulectomy during the period from June 2019 through December 2022 formed the study cohort. We performed assessment of pathology of vestibular tissues by use of immunohistochemical staining, including quantitation of mast cells by CD117 (mast cell marker) and nerve fibers by protein gene product (PGP) 9.5 (neuronal marker). We analyzed 725 photomicrographs of immunostained tissue sections (100× and 200×) by manual counting and computer-assisted histometry and correlated these data to clinical assessments. Outcomes included density of CD117 and PGP9.5 immunostaining in the 1:00-11:00 o'clock and 12:00 o'clock vestibular regions, and patient-reported outcomes assessing sexual function, pain, distress, and symptom improvement. All 65 NPV patients (median age 26 years), 45 with lifelong and 20 with acquired NPV, had severe pain documented by PROs and vulvoscopy and had >8 CD117-immunopositive cells/100× microscopic field. Median cell count values were similar in the 1:00-11:00 o'clock and 12:00 vestibular regions (28.5 and 29.5/100× field, respectively). Likewise, the marker) and nerve fibers by protein gene product (PGP) 9.5 (neuronal marker). We analyzed 725 photomicrographs of immunostained tissue sections (100× and 200×) by manual counting and computer-assisted histometry and correlated these data to clinical assessments. Outcomes included density of CD117 and PGP9.5 immunostaining in the 1:00-11:00 o'clock and 12:00 o'clock vestibular regions, and patient-reported outcomes assessing sexual function, pain, distress, and symptom improvement. All 65 NPV patients (median age 26 years), 45 with lifelong and 20 with acquired NPV, had severe pain documented by PROs and vulvoscopy and had >8 CD117-immunopositive cells/100× microscopic field. Median cell count values were similar in the 1:00-11:00 o'clock and 12:00 vestibular regions (28.5 and 29.5/100× field, respectively). Likewise, the median area of CD117 immunostaining was similar in both regions (0.69% and 0.73%). The median area of PGP9.5 immunostaining was 0.47% and 0.31% in these same regions. Pain scores determined with cotton-tipped swab testing were nominally higher in lifelong vs acquired NPV patients, reaching statistical significance in the 1:00-11:00 o'clock region (P < .001). The median score for the McGill Pain Questionnaire affective subscale dimension was also significantly higher in lifelong vs acquired NPV patients (P = .011). No correlations were observed between hematoxylin and eosin results and density of mast cells or neuronal markers. Of note, 63% of the patient cohort reported having additional conditions associated with aberrant mast cell activity. The pathology of NPV is primarily localized to the vestibular epithelial basement membrane and subepithelial stroma with no visible vulvoscopic findings, making clinical diagnosis challenging. Strengths of this study include the large number of tissues examined with what is to our knowledge the first-ever assessment of the 12:00 vestibule. Major limitations are specimens from a single timepoint within the disease state and lack of control tissues. Performing immunohistochemical staining of excised vestibular tissue with CD117 and PGP9.5 led to histometric confirmation of NPV, indications that NPV is a field disease involving all vestibular regions, validation for patients whose pain had been ignored and who had experienced negative psychosocial impact, and appreciation that such staining can advance knowledge.

Efficacy of in-office lysis of clitoral adhesions with excision of keratin pearls on clitoral pain and sexual function: a pre-post interventional study.

Keratin pearls are foci of central keratinization within concentric layers of squamous cells that can form under the clitoral prepuce and cause pain (clitorodynia); in-office removal of keratin pearls may reduce clitoral pain and improve sexual function. This study aims to investigate clitoral pain and sexual function in women with partial clitoral phimosis and keratin pearls before and after in-office lysis of clitoral adhesions with keratin pearl excision (LCA-KPE). A pre-post interventional study evaluated patients who underwent LCA-KPE between January 2017 and February 2023 in 2 metropolitan gynecology clinics specializing in vulvar pain. Patients presenting with keratin pearls and partial clitoral phimosis identified through retrospective chart review were asked to complete postprocedure questionnaires and provide subjective responses on clitoral discomfort, sexual function, sexual distress, and their experience with in-office LCA-KPE. Bivariate analyses with paired t tests were conducted to determine the effect of LCA-KPE. Qualitative data were analyzed with thematic coding. An 11-point pain visual analog scale was utilized to determine pre- and postprocedure clitoral discomfort and difficulty with orgasm. Female sexual dysfunction was measured with the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised. A total of 32 of 74 patients who met inclusion criteria completed postprocedure surveys (43% response rate). Mean clitoral pain for respondents was 6.91 at baseline and 2.50 after LCA-KPE (P < .001). Mean difficulty with orgasm was significantly decreased from 5.45 at baseline to 3.13 after LCA-KPE (P < .001). Participants had a mean FSFI total score of 17.68 after treatment compared with a mean total baseline FSFI of 12.12 (P = .017). The mean FSFI score for pain was 2.43 at follow-up compared with 1.37 at baseline (P = .049). There was no significant difference in the mean Female Sexual Distress Scale-Revised score before vs after the procedure (P = .27). Qualitative themes described the procedure as painful but worthwhile, with 77% of participants reporting the overall experience as positive. Recurrence rate overall was 28%, with a median of 2 repeat procedures. Recognizing keratin pearls as a structural cause of clitoral pain and offering in-office treatment is an important tool in addressing clitorodynia and improving sexual function. This is the largest study to date documenting the occurrence, identifying associated pain conditions, and evaluating procedural outcomes for clitoral keratin pearls. This study was limited by a relatively small sample size. In-office LCA-KPE significantly reduced clitoral discomfort and difficulty with orgasm.

Effects of Group Mindfulness-Based Cognitive Therapy versus Supportive Sex Education on Sexual Concordance and Sexual Response Among Women with Sexual Interest/Arousal Disorder

ABSTRACT Low interest in sexual activity and impaired sexual response are among women’s most frequent sexual concerns. Mindfulness-based treatments improve low sexual desire and arousal and associated distress. One theorized mechanism of change is the cultivation of increased mind-body awareness via greater concordance between psychological and physiological components of sexual response. We examined sexual psychophysiology data from 148 cisgender women randomized to receive mindfulness-based cognitive therapy (MCBT: n = 70) or supportive sex education (STEP: n = 78) over eight weekly group sessions. Women completed in-lab assessments of subjective, affective, and genital sexual responses to an erotic film pre- and post-treatment, and at 6- and 12-month follow-ups. Both groups showed positive changes in sexual and affective responses, but these were generally more pronounced for MBCT. MCBT increased sexual concordance to a greater degree, and gains in sexual concordance predicted improvements in sexual distress throughout treatment.

A randomized comparison of online mindfulness-based group sex therapy vs supportive group sex education to address sexual dysfunction in breast cancer survivors.

Sexual difficulties and vaginal pain are common following treatment for breast cancer. The goal of this study was to evaluate an online mindfulness-based group sex therapy vs an online supportive sex education group therapy to address these sexual difficulties. Breast cancer survivors (n= 118) were randomized to 1 of the 2 arms; 116 provided informed consent and completed the time 1 assessment. Treatment included 8 weekly 2-hour online group sessions. Those randomized to the mindfulness group completed daily mindfulness exercises, and those in the comparison arm read and completed exercises pertaining to sex education. Assessments were repeated at posttreatment and 6 months after the completion of the group. There was a main effect of treatment on primary endpoints of sexual desire, sexual distress, and vaginal pain, with all outcomes showing significant improvements, with no differential impact by treatment arm. Secondary endpoints of interoceptive awareness, mindfulness, and rumination about sex also significantly improved with both treatments, with no group-by-time interaction. Both mindfulness-based sex therapy and supportive sex education delivered in group format online are effective for improving many facets of sexual function, vaginal pain, rumination, mindfulness, and interoceptive awareness in breast cancer survivors. We used a randomized methodology. Future studies should seek to diversify participants. These findings highlight the need to offer similar treatments to more breast cancer survivors immediately after and in the years following cancer treatment as a means of improving survivorship quality of life.

Vulvovaginal atrophy in women with and without a history of breast cancer: Baseline data from the PatiEnt satisfactiON studY (PEONY) in Italy

ObjectivesTo assess clinical characteristics of postmenopausal women with moderate/severe vulvovaginal atrophy, as well as its impact on sexual function, well-being, and quality of life, and to provide an overview of most used treatments. Study designOngoing longitudinal, observational study conducted in 17 Italian gynecology centers, involving women already treated or initiating a local vaginal estrogen therapy or ospemifene. We report baseline data for women with and without a history of breast cancer. Participants filled in self-reported questionnaires at study entry. Main outcome measuresSeverity of vulvovaginal atrophy; ongoing treatments; patient-reported outcomes, including severity of symptoms, Day-to-Day Impact of Vaginal Aging (DIVA), Female Sexual Function Index (FSFI), Female Sexual Distress Scale-Revised (FSDS-R), and SF-12® Health Survey. ResultsOverall, 334 women (20.4 % with a history of breast cancer) started or continued local therapy (61.1 %) or ospemifene (38.8 %) at study entry. Vulvovaginal atrophy was severe in 28.6 %, and was responsible for severe symptoms, particularly vulvar dryness with burning or irritation and pain during sexual intercourse. Both sexual dysfunction (FSFI≤26) (81.5 %) and sexual distress (FSDS-R ≥ 11) (74.4 %) were common. A reduction in the SF-12 mental component score was documented. Women with breast cancer more often had severe vulvovaginal atrophy (41.2 %), had more severe symptoms, and the impact of vaginal symptoms on emotional well-being, sexual functioning and self-concept/body image was greater. The majority of them (83.8 %) received ospemifene as a treatment. ConclusionsModerate/severe vulvovaginal atrophy is a common, often neglected condition with an impact on QoL and sexuality, particularly in women with a history of breast cancer. It is important to alleviate the burden associated with the disease.

(269) Distress with Sexual Function in LGB+ Individuals: Proposal for a Scoping Review

Abstract Introduction Distress associated with sexual function, usually described as “sexual distress” is typically defined as an intense negative emotional experience. It has gained significant attention in research, mainly due to its inclusion as a mandatory criterion for diagnosing sexual dysfunctions (SD). Literature suggests that sexual distress with sexual function can have wide-ranging implications, negatively affecting mental health, relationship dynamics, and overall well-being. Studies specifically targeting LGB+ (lesbian, gay, bisexual, and other minority sexual orientations) people reveal that lesbian women commonly report distress related to sexual pain, difficulties with arousal, and low interest and desire for sexual activities. Additionally, research has indicated a high prevalence of sexual dysfunctions among gay men (e.g., erectile dysfunction). Regarding bisexual people, women in same-gender relationships may have high levels of sexual pain when compared with women in mixed-gender relationships. Furthermore, men in same-gender-oriented relationships reported a higher frequency of sexual problems when compared to men in mixed-gender relationships, who frequently reported anodyspareunia and difficulties with erect function. Objective Given the reported existence of sexual distress with sexual function in LGB+ people, exploring its specific correlates in LGB+ people is crucial, expanding knowledge in this field. We seek to answer the following research question: "What does the literature report/describe about sexual distress in LGB+ people and its correlates?". We aim to map all knowledge and gaps as well as clinical and research implications related to sexual distress in LGB+ people. Methods We will develop a scoping review guided by Arksey and O'Malley's framework (2005) and follow PRISMA guidelines and an open-science framework. We will consider relevant information such as publication year, country, sample demographics, methodological approach, study objectives, variables associated with sexual distress in LGB+ people, presence of a diagnosis of SD, comorbidity, and primary outcomes (e.g., sexual distress levels, sexual function, help-seeking behaviors). The search will be conducted on indexed databases (i.e., PubMed, APA PsycInfo, Scopus, and Web of Science Core Collection). Inclusion criteria are studies about sexual distress with sexual function with LGB+ people. The exclusion criteria are non-English studies and gray literature. The review will not restrict the data range of included studies and will consider both peer-reviewed and non-peer-reviewed sources. The articles provided will be subjected to quantitative descriptive statistics and qualitative content analysis to synthesize the literature. The search string will include terms such as, for example, (sexual* distress* OR sexual* concern OR sexual* bother) AND (psychological OR individual OR personal OR interpersonal OR relation* OR marital OR couple) AND (LGB+ people OR sexual minority OR non-heterosexual). Results We aim to identify existing theoretical and methodological approaches, flaws, and gaps. We hope to reach a comprehensive look at existing results in the field, opening room for future research while also aggregating clinically meaningful information. Conclusions This scoping review will be useful for researching and practicing sexual medicine with LGB+ people. Disclosure No.

(120) E-Mergir: Preliminary Efficacy of a Digital Psychological Intervention Program for Improving Mental Health, Sexual Health, and Quality of Life of Prostate Cancer Survivors

Abstract Introduction Introduction: Prostate cancer is one of the most common cancers affecting men worldwide. The diagnosis of prostate cancer and associated treatments have a negative impact on people's physical, emotional, and sexual health, compromising their overall well-being and quality of life throughout the course of the disease. Despite the decreased levels of sexual functioning and sexual satisfaction associated with this type of cancer (Quinta-Gomes et al., 2019), patients' access to specialized healthcare and support is still limited. Given their flexibility and convenience, smartphone-based digital interventions can contribute to bridging this gap and constitute an important way to access specialized and personalized supportive care on emotional and sexual health for people with prostate cancer. Objective Objective: The present study aims to evaluate the preliminary efficacy of a digital psychological intervention program using smartphones aimed at improving the mental health, sexual health, and quality of life of prostate cancer survivors. Methods Methods: A randomized controlled pilot study is underway involving 30 prostate cancer survivors randomly assigned to an experimental group (with access to the program) and a waiting list control group (treatment as usual). The program was structured in five modules to be completed by the participants in a maximum period of 6 weeks while receiving support from a psychologist. The study was approved by an institutional Ethical Board. Acceptability, usability, feasibility, and preliminary efficacy (overall improvement in sexual and relational satisfaction, sexual pleasure, sexual distress, psychopathology, and quality of life) were defined as the main outcomes of this study. Participants' assessments will take place in two moments, before and after the implementation of the program. Results Expected results: It is expected that the program and the experimental design adopted will prove to be adequate and have good acceptability by the participants. Improvements in sexual and relational satisfaction, sexual pleasure, sexual distress, psychopathology, and quality of life are also expected for participants using the program compared to those in the waiting-list group. Conclusions Conclusions: As a future empirical-based digital psychological intervention program focused on patients' unmet sexual needs, E-mergir will significantly contribute to addressing the emotional and sexual health and quality of life of people with prostate cancer. Funding: Horizon Europe, NORTE-01-0145-FEDER-000057, CCDRN Disclosure No.

(119) Anathema: Pilot Study to Assess the Acceptability, Feasibility, and Preliminary Efficacy of a Digital Intervention to Promote Sexual Health in Colorectal Cancer Survivors

Abstract Introduction Introduction: Sexual health is a central dimension of overall health and quality of life, yet it remains a largely neglected component in vulnerable populations such as cancer patients. Colorectal cancer (CRC) is currently one of the most prevalent types of cancer worldwide, and its treatments negatively affect people's sexual and relational health and well-being throughout the course of the disease. Notwithstanding the negative impact of treatments on different dimensions of sexual functioning (e.g., changes in sexual desire, sexual arousal, and orgasm experience), on the experience of pleasure and sexual satisfaction of people with CRC, access to specialized support is often hampered due to organizational, geographical, and attitudinal barriers (e.g., stigma). Given their intimate nature, accessibility, and convenience/flexibility, smartphone-based digital interventions can help bridge this gap and be an important supportive tool to effectively address unmet sexual health care needs in people with CRC. However, there is still a lack of studies evaluating the acceptability, feasibility, and effectiveness of smartphone-based sexual health promotion programs for people with CRC. Objective Objectives: The objective of this study is to evaluate the acceptability, feasibility, and preliminary efficacy of Anathema, a program developed for the promotion of the sexual health of CRC survivors. Methods Methods: A randomized controlled pilot study is underway and involves 30 CRC survivors randomly assigned to an experimental group (with access to the program) and a waiting list control group (treatment as usual). The program was structured into five modules to be completed in 8 weeks and developed based on the principles of Cognitive-Behavioral Therapy. An institutional Ethical Board approved the study. Acceptability, usability, and feasibility of Anathema were the primary outcomes defined in this study. Sexual and relational satisfaction, sexual functioning and distress, sexual pleasure, and quality of life were defined as secondary outcomes. Results Results: The participatory design used throughout the different phases of this project anticipates a good acceptability of the program among its primary users. It is also expected that the program and the design adopted will be suitable for the future implementation of an RCT. Improvement in levels of sexual and relationship satisfaction, sexual pleasure, quality of life, and a decrease in levels of sexual distress in people who use the program compared to people in the waiting list group, are also expected. Conclusions Conclusions: Anathema is a promising program for promoting sexual health and quality of life in CRC survivors. Funding source: This project is jointly funded by the European Commission through the AAL Program (ref. AAL-2020-7-133-CP) and its Member States: Fundação para a Ciência e a Tecnologia, in Portugal (AAL/0005/2020), Austrian Research Promotion Agency (FFG), in Austria, and ZonMw, the Netherlands Organization for Health Research and Development, in the Netherlands. Disclosure No.

Guided internet-based acceptance and commitment therapy for provoked vestibulodynia: A randomized controlled trial.

Provoked vestibulodynia (PVD) causes suffering in many women's lives due to its impact on relationships, sexual functioning and functioning in other key domains. Here, we report a randomized controlled trial conducted to examine whether Acceptance and Commitment Therapy (ACT) with a focus on values-based exposure, delivered online, benefits women with PVD. Participants (n = 88) were randomized to either guided online ACT for 10 weeks or a wait-list control group. Outcomes were assessed at baseline, post treatment and 1 year later. Analyses were based on intention to treat using linear mixed models. There were significant group differences on the primary outcomes, Female Sexual Index and Female Sexual Distress Scale, in favour of online ACT with moderate effect sizes. Differences were also found on several secondary outcomes and therapeutic process measures, all in favour of ACT. No differences were found at post-treatment for depression or anxiety. At the 1-year follow-up, results were maintained and a difference between baseline and follow-up was also found for depression. In summary, a relatively brief, guided, online version of ACT appears to produce benefits for women with PVD and related impacts on daily functioning. 50% to 60% of the women who participated in the treatment reliably improved in sexual functioning and distress.

State of the science of sexual health among older cancer survivors: an integrative review.

Sexual health is important for quality of life among older (≥65 years) cancer survivors. Yet, little is known about the extent to which their sexual health has been studied. In this integrative review, PubMed, PsycINFO, CINAHL, and Web of Science were searched for data-based articles of sexual health among older cancer survivors. Using a matrix, study characteristics, including cancer types and areas of sexual health, were categorized. The sample included 82 articles (81 studies). The areas of sexual health were categorized into sexual function, body image, sexual function-related distress, sexual health-related quality of life, sexual activity, sexual enjoyment, and sexual desire. Most targeted prostate cancer (n = 56, 69.1%) and studied sexual function, e.g., erectile function (n = 53, 94.6%). Body image (n = 16, 19.8%) was next frequently studied, targeting women with breast cancer. Measures to assess areas of sexual health, largely unstandardized, varied widely. Generally, older cancer survivors reported negative changes in sexual function and other areas during and after cancer treatment. Studies of sexual health among older cancer survivors have been focused primarily on prostate cancer, male, and sexual function. Together with the lack of standardized sexual health measures validated for older adults, this narrow research focus contributes to the limited body of knowledge regarding sexual health among older cancer survivors. Given that cancer and cancer treatment affect both men and women and many aspects of sexual health beyond functioning, broadening the scope of sexual health and cancer type is warranted for future research.

(097) Psychosocial Factors in PGAD/GPD Patients Who Underwent Spine Surgery for Lumbosacral Annular Tear-Induced Sacral Radiculopathy

Abstract Introduction Persistent genital arousal disorder/genito-pelvic dysesthesia (PGAD/GPD) is characterized by persistent or recurrent, unwanted or intrusive, distressing sensations of genital arousal not associated with concomitant sexual interest, thoughts, or fantasies and/or other symptoms of GPD (e.g. itching, burning, throbbing, pain) that persist for ≥3 months. Multiple psychological and medical factors may contribute to the development and maintenance of PGAD/GPD. Concerning psychologic factors, women afflicted with PGAD experience more than double the rate of suicidal ideation (54%) compared to a control group, difficulty with mental health issues such as depression, high rates of negative emotions, and substantial difficulties with psychosocial adjustment. Objective This study focuses on psychosocial factors identified in a cohort of PGAD/GPD patients diagnosed with lumbosacral annular tear-induced sacral radiculopathy. Methods Using our multidisciplinary spine-sexual medicine management algorithm, 20 patients (15 cisgendered women, 5 cisgendered men, mean age 40.3 ± 16.8 years) diagnosed with PGAD/GPD fulfilled criteria for lumbosacral annular tear-induced sacral radiculopathy. A total of 22 lumbar endoscopic spine surgery (LESS) procedures were performed in these 20 patients. Validated instruments administered included the Sexual Distress Scale-Revised, Perceived Stress Scale, and Patient Health Questionnaire-9. The sex therapy evaluation performed on initial patient intake assessed psychosocial issues including effect of symptoms on quality of life, self-image, past trauma, and current relationship(s). Patients identified as having significant psychosocial issues were advised to undergo pre-op and/or post-op therapy. Results Ninety percent of patients were advised to undergo therapy. Our study cohort exhibited high levels of anxiety, depression, and/or obsessive-compulsive disorder as well as suicidal ideation. The Sexual Distress Scale–Revised revealed significant distress in 14 patients (82%). The Perceived Stress Scale showed 2 (12%) having high stress, 12 (70%) having moderate stress, and 3 patients (18%) having low stress. As assessed by item 1 of the Patient Health Questionnaire-9, 3 patients had a score consistent with warranting treatment for depression while an additional 10 had a score consistent with the possible need for treatment based on clinical judgment. As assessed by item 2 (“How difficult is it for you to do your work, take care of things at home, or get along with other people?”), 13 (65%) reported difficulties, with 3(15%) extremely difficult, 5 (25%) very, and 5 (25%) somewhat difficult. Overall, 7 (35%) showed improvement on the Patient Global Impression of Improvement after 3 months and by one year post-operatively, 80% (16/20) reported improvement. Conclusions There are many recognized triggers for PGAD/GPD. While this subgroup was diagnosed with lumbosacral annular tear-induced sacral radiculopathy and experienced long-term alleviation of symptoms by LESS, psychological factors likely contributed to the development, continuation, and consequences of PGAD/GPD. We believe that the significant mental health issues in this PGAD/GPD patient population made recovery from LESS more protracted than typically experienced after this surgery for sciatica alone. Psychological therapy would be beneficial in this population and should be continued postoperatively, as needed, to address psychological concerns and enhance quality of life. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Eliquence.

(272) Botulinum Toxin Injection in Vulva and Vagina: Evidence from a Literature Systematic Review

Abstract Introduction Vaginismus, vulvodynia and chronic pelvic pain are a group of pain syndromes that may have, in addition to pain, other types of symptoms. Often no specific etiology can be identified, and the choice of treatment is complicated. Although several treatment methods have been proposed, evidence-based therapies are limited. Therapies can be classified in medical, surgical and interventional treatment. Interventional therapy contemplates injection therapy with botulinum toxin, proposed in 1997 Objective To evaluate the BoNT injection in the comprehensive care of vaginismus, vulvodynia and chronic pelvic pain and to enhance the impact on the sexual arousal. Methods 1108 patients, Randomized Controlled Trials (RCT) were 7. The Retrospective Studies Without a control group were 4, With a control group: 1. Besides, the Prospective Studies Without a control group were, . 2 patients were With a control group. The BoNT Dosage Range was: Minimum: 12 UI Maximum: 500 UI Types of BoNT Products: Botox® (onabotulinumtoxinA): 14 Xeomin® (incobotulinumtoxinA): 3 Dysport® (abobotulinumtoxinA): 3 Unspecified BoNT Product: 1 EMG-Guided Injection: 5 I used as BoNT Administration Techniques, the Digital Palpation: 12, the unspecified Injection Procedure: 4. My methods were 17 patients in Intramuscular Injection, 3 patients with Vaginal Submucosal Plane, and one patient with Subcutaneous Injection. Results For Vaginismus, Significant improvement in sexual and orgasmic dysfunction Successful intercourse Reduction of vaginal muscle resistance Improved sexual function (evaluated by Female Sexual Function Index) Pain reduction and improved quality of life (Short-Form Health Survey) BoNT reduced muscular hyperactivity. Both BoNT and placebo improved sexual pain, function, and distress for patients with vulvodynia, Significant improvement in pain 4, improved quality of life 2 and increase of sexual activity due to the reduced pelvic hypertonicity. Other Study Results: Significant improvement in pelvic pain [22, 23, 31, 32] Reduction of vaginal pressure [32] Improvement in quality of life, sexual activity, and reduced pelvic floor muscles myoelectrical activity [31] Conclusions Different endpoints and different methods of analysis. Different types of participants. Various techniques and timing. Adverse events. For this reason, even though BoNT seems a promising treatment, a clear standardization in clinical guidelines is still lacking. A clear standardization is needed for practical guidelines. Future perspectives should address reproducible protocols for BoNT administration. Disclosure No.

(266) Miconazole Vaginal Cream-Induced Acquired Neuroproliferative Vestibulodynia

Abstract Introduction The endodermal vestibule lies between the ectodermal vulva and the mesodermal vagina. Unlike the vulvar skin, the vestibular epithelium is thin, non-keratinized, and its submucosal immune cells are more susceptible to activation. Topical pharmaceutical agents that are applied to the genitals for various medical indications are likely to contact the vestibular epithelium. For example, miconazole vaginal cream (MVC) is approved for treatment of vaginal yeast infections and the irritation associated with the yeast infection. Active and inactive ingredients in MVC include miconazole nitrate, benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water and stearyl alcohol. We have observed cases where individuals, previously without vestibular pain, have applied MVC to their genitals and immediately experienced excruciating burning that resulted in persistent unrelenting severe pain throughout the vestibule, which is a symptom of acquired neuroproliferative vestibulodynia (ANPV). Objective Our objective is to report cases of patients who used MVC and were diagnosed with ANPV in order to provide awareness of this condition. Methods We performed a retrospective chart review of persons with vulvas presenting to a single sexual medicine clinic between 6/2019-6/2023 who were clinically suspected to have ANPV after experiencing an allergic reaction following use of MVC. Patients were included who failed conservative treatments for provoked vestibular pain, underwent vestibulectomy and were histopathlogically diagnosed with ANPV (&amp;gt;8 CD117 stained immunopositive cells per high-power field (HPF), consistent with mast cells, and excess PGP117 stained immunopositive cells, consistent with nerves). Demographic data, prior diagnoses and treatments, and results from validated questionnaires were collected. Results Our patient cohort included 7 individuals who met the criteria for MVC-induced ANPV. Mean age at time of MVC-induced vestibular pain was 23 (range 18-29) years. Mean age of presentation to our sexual medicine facility was 28 (range 22-33) years. Mean years of delay in diagnosis of MVC-induced ANPV was 5 (range 1-12) years. 71% and 29% were previously diagnosed and unsuccessfully managed as hormone-mediated vestibulodynia and interstitial cystitis, respectively. The mean pain score and overall score for the Female Sexual Function Index (FSFI) was 1.2/6 (range 0-3.2/6) and 11.7/36 (range 4.2-18.1/36), respectively. All total FSFI scores were &amp;lt;26 and indicative of sexual dysfunction. The mean Female Sexual Distress Scale-Revised score was 32.2/52 (21-39/52), consistent with significant distress. Conclusions Our cohort of patients with MVC-induced ANPV experienced several years of misdiagnoses, unsuccessful treatments, and significant pain and distress. It is hypothesized that MVC induces ANPV in genetically susceptible individuals possibly due to activation of the innate submucosal immune cells from an allergic reaction to active or inactive ingredients in the MVC. This allergic reaction results in accumulation of mast cells in the subepithelial stroma that release cytokines and growth factors leading to proliferation of nerves with subsequent symptoms of allodynia and hyperalgesia. Avoidance of topical medications and use of systemic antifungal strategies in individuals with yeast infections may be advisable. Disclosure No.

(123) Preliminary Efficacy of Sildenafil Cream, 3.6% in an Exploratory, Randomized, Placebo-Controlled, Phase 2b Trial for the Treatment of Female Sexual Arousal Disorder

Abstract Introduction Female sexual arousal disorder (FSAD) is a persistent or recurrent inability to attain, or to maintain until completion of the sexual activity, an adequate lubrication-swelling response of sexual excitement that causes marked distress or interpersonal difficulty. The biologic mechanisms leading to FSAD are similar to male erectile dysfunction. Objective To test the preliminary efficacy of topical Sildenafil Cream, 3.6% among women with FSAD in a randomized, placebo-controlled, double-blind, exploratory Phase 2b study. To describe, using validated 28-day recall instruments, changes in sexual function with treatment, and to validate exploratory sexual function questionnaires in a placebo-controlled trial. Methods Healthy pre-menopausal women, aged 18-years or older and their sexual partners, if applicable, were screened and provided written informed consent. An individual clinical interview with each volunteer was conducted in order to establish that FSAD was present and was the primary sexual dysfunction concern. Women at risk of pregnancy used effective contraception during the study. Women or their partners were excluded if they had un-controlled hypertension, a history of serious cardiac events (e.g. myocardial infarction, stroke), orthostatic hypotension or other serious medical co-morbidities. The co-primary efficacy endpoints were measured by the arousal sensation domain of the sexual function questionnaire (SFQ28) and question 14 of the female sexual distress scale (FSDS). After a one-month, no drug, run-in period, and a one-month, single-blind placebo, run-in period, 200 eligible women were randomized to receive Sildenafil Cream, 3.6% (n=101) versus placebo cream (n=99). Participants applied 2 grams of the investigational product to the clitoris, vestibule, labia minora and anterior distal vagina 10 – 20 minutes prior to each partnered or un-partnered sexual experience. During the 12-week, double-blind treatment period, participants were seen monthly and completed validated, 28-day recall questionnaires. Efficacy was also measured by a 12-question Arousal Diary (AD), completed within 24 hours of each sexual experience. Results Volunteers (n=833) underwent informed consent in this ethics board (Advarra Pro 00049161) and U.S. Food and Drug Administration approved study (IND 119922), registered at ClinicalTrials.gov (#NCT04948151). There were 1131 Sildenafil and 951 placebo exposed sexual experiences recorded in the AD during the double-blind treatment period. Sildenafil Cream, 3.6% treated women had a higher proportion of satisfactory sexual events than placebo users. At 12-weeks of use, there was improvement in the co-primary endpoint of arousal sensation consistent with how women reported meaningful improvement in an exit interview at the end of the study, although this did not achieve statistical significance. Sildenafil Cream, 3.6% treated women showed improvements in pre-specified exploratory endpoints that evaluated various aspects of the sexual experience including desire (p=0.02), arousal lubrication (p = 0.059) and orgasm (p=0.066) after 8 weeks of product use. Conclusions Data from this exploratory, placebo-controlled study of topical Sildenafil Cream, 3.6% for the treatment of FSAD in healthy premenopausal women support further clinical development of this first potential treatment for FSAD. Disclosure Yes, this is sponsored by industry/sponsor: Dare Bioscience and Strategic Sciences and Technologies (SST), LLC. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Dare Bioscience and SST LLC.

Safety and efficacy of a class II medical device based on highly purified and standardized plant extracts in the management of post-menopausal patients with vulvar and vaginal atrophy: a single-center prospective observational study.

Despite the gold standard treatment for genitourinary syndrome of menopause (GSM) is based on the use of local or systemic estrogen-containing products, the typical long-term side effects of hormonal treatments and, most importantly, the contraindications in patients with history of breast and endometrial neoplasms do limit in some extent its use. As hyaluronic acid and some highly purified botanicals have clearly demonstrated their anti-inflammatory and mucosa-protecting properties, we have tested, in women with GSM, a class II vaginal medical device containing hyaluronate gel and a mucoadhesive active enriched with purified alkylamides from Zanthoxylum bungeanum, triterpenes from Centella asiatica and high molecular weight polysaccharides from Tamarindus indica. Our single-center, open-label, prospective and observational study was conducted on 50 menopausal women enrolled at the Department of Maternal-Fetal Medicine at Umberto I Polyclinic Hospital in Rome, Italy. Gel administration lasted 150 days and was performed daily for the first 12 days and every 48 hours for the remaining 138 days. Clinical evaluations were performed at baseline and after 12, 57 and 150 days. Besides product safety, main outcomes of our study were: 1) vaginal health (by Vaginal Health Index score [VHI]); 2) sexual quality of life (by Female Sexual Distress Scale [FSDS]); and 3) percentage of women declaring regular sexual activity. The product was safe with no specific adverse events reported. It significantly improved VHI (about 5% after 57 days and 8% after 150 days), FSDS (about 7% after 57 days and 10% after 150 days), and sexual activity (about 20% after 150 days). It also reduced dryness, dyspareunia, burning, itching, and dysuria incidence, respectively by about 18%, 14%, 14%, 27% and 11% after 150 days. In women with GSM, the intravaginal administration of a hyaluronate-based gel enriched with purified botanical actives endowed with anti-inflammatory and mucosal-protecting properties, reduced painful sensation during sexual acts and increased regular sexual activity.

A survey of patient tolerance and satisfaction with capsaicin for neuroproliferative vestibulodynia.

Topical capsaicin has been used to treat vulvodynia but has been poorly studied for use in neuroproliferative provoked vestibulodynia (PVD); capsaicin decreases allodynia by blocking vanilloid receptors (TRPV1) on C-afferent nociceptors, but the therapy causes discomfort to the point of intolerance in some patients. The present study evaluated tolerability and efficacy of topical capsaicin to treat neuroproliferative PVD. Patients with neuroproliferative PVD prescribed 0.025% capsaicin compounded in VersaBase cream were identified through prescription records. Outcome measures included the Female Sexual Function Index (FSFI), the Female Sexual Distress Scale-Revised, and a 22-question questionnaire assessing patient experience and treatment tolerability. Among tolerant patients, capsaicin significantly decreased vestibular pain, but tolerance was highly variable. Twenty-five patients responded to the follow-up questionnaire. The average age at presentation was 30years (range, 18-52years). Eighty percent of patients tolerated capsaicin application for the full 20minutes within a median time of 1 to 2weeks. Of the 16 patients reporting tolerance to 20-minute application, 12 (60%) experienced improvement in vestibular pain. On an 11-point numeric rating scale, the mean pain score was 8.96 and the median score was 10 with first application. Among all participants, 16 (64%) had reduction in pain during treatment. Fifty-six percent of patients would recommend capsaicin as a treatment for vulvar pain. Qualitative content analysis focused on categories of efficacy, value, and feasibility, which indicated that those able to tolerate the treatment experienced improvement while using the medication. The mean Female Sexual Distress Scale-Revised score was 35.96 at baseline compared with 25.09 at follow-up (P< .0001). On a numeric rating scale, the mean self-reported vulvar pain score was 8.2 at baseline compared with 5.35 when using capsaicin consistently (P< .0001). The mean FSFI pain domain score was 2.45 at baseline compared with 0.98 at follow-up (P= .005). While not statistically significant, the mean total FSFI score was 15.44 at baseline compared with 17.84 at follow-up (P= .3730). Capsaicin is helpful for some patients with PVD, but thorough counseling is important because of highly variable tolerance. Strengths include examination of a poorly studied therapy and inclusion of narrative responses from patients to inform counseling. Limitations include small sample size, retrospective design, and low survey response rate. Patients should be appropriately selected and thoroughly counseled given high levels of intolerance, but capsaicin therapy may be considered for patients with neuroproliferative PVD who have failed conservative treatments and wish to avoid surgery.

Safety and efficacy of non-ablative CO2 laser treatment of vulvo-vaginal atrophy in women with history of breast cancer.

Breast cancer survivors (BCS) suffer severe vulvo-vaginal atrophy (VVA) and some of the most effective therapies are contraindicated. In literature we have no data about the non-ablative CO2 laser on these women. The aim of this study was to examine its efficacy, safety and acceptability in BCS. The enrolled women underwent 3 sessions of laser therapy (t0, t1, t2) and a one-month follow up examination (t3). At each time point we measured objective signs of VVA via VHI (Vaginal Health Index) and VuHI (Vulvar Health Index) and subjective parameters (Dryness, Burning, Itching, Dysuria) via visual analog scales (VAS). In sexually active women we evaluated the sexual function with FSFI (Female Sexual Function Index), FSDS (Female Sexual Distress Score) scores and MENQOL (menopause quality of life questionnaire). We enrolled 26 BCS. The mean VHI, VuVHI, dryness and burning VAS scores improved significantly and this improvement was not influenced by the initial VVA grade. MENQOL sexual domain, Lubrication, Orgasm and Pain domains and FSFI total score improved significantly, while Desire, Arousal and Satisfaction domains of FSFI and FSDS did not. At t0 women using Aromatase Inhibitors suffered more severe vaginal dryness than women using Tamoxifen or no therapy, but the three subgroups improved without differences. No adverse event and minimum discomfortwere reported. The non-ablative CO2 laser is a safe and effective treatment of VVA and has positive effects on sexual function in BCS regardless the use of adjuvant therapies and the initial grade of VVA.

Quality of Life and Sexual Function after Laparoscopic Posterior Vaginal Plication Plus Sacral Colpopexy for Severe Posterior Vaginal Prolapse.

Laparoscopic sacral colpopexy (LSC) is the gold standard treatment for women with apical/anterior pelvic organ prolapse (POP). For isolated posterior vaginal prolapse, instead, the literature suggests fascial native tissue repair. This is a retrospective 2-year quality-of-life follow-up study after laparoscopic posterior plication (LPP) combined with LSC in patients with anterior/apical prolapse combined with severe posterior colpocele. The primary endpoint was to evaluate the subjective outcomes quality of life (QoL), sexual function, and patient satisfaction rate. The secondary endpoint was to evaluate perioperative and anatomical outcomes at the 2-year follow-up. A total of 139 consecutive patients with anterior and/or apical prolapse (POP-Q stage ≥ II) and severe posterior vaginal prolapse (posterior POP-Q stage ≥ III) were retrospectively selected from our database among women who underwent, from November 2018 to February 2021, a "two-meshes" LSC. The patients were classified into Group A (81 patients; LSC plus LPP) and Group B (67 patients; LSC alone). The primary endpoint was evaluated using the Patient Global Impression of Improvement (PGI-I), the Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6), the Pelvic Floor Impact Questionnaire-7 (PFIQ-7), the Female Sexual Distress Scale (FSDS), the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), and the EuroQol (EQ-5D). The secondary endpoint was studied using the POP-Q study and an intra-, peri-, and post-operative complications assessment. Two-year follow-up data were analyzed for the study. At 2 years, all women showed a statistically significant amelioration of their symptoms on the QoL questionnaires. We found a statistical difference in favor of posterior plication in terms of the PGI-I successful outcome rate (Group A versus B: 85.3% versus 67.1%), FSDS (median 11 versus 21), and PISQ-12 (median 89 versus 62) (p < 0.05 for all comparisons). A significant improvement of all EQ-5D values was observed from baseline to 2-year follow-up, and only for the "pain/discomfort" domains did we observe a significant improvement in LSC plus LPP patients versus LSC alone (p < 0.05). LSC plus LPP women showed, at 2 years, a significant amelioration of their Ap and GH POP-Q points. We observed no statistical differences in terms of intra-post-operative complications or anatomic failure rate between groups. Our LPP approach to LSC appears to be a safe, feasible, and effective treatment for advanced pelvic organ prolapse with a significant impact on the patient's general health and sexual quality of life. Adding laparoscopic posterior vaginal plication to "two-meshes" sacral colpopexy is recommended in patients with apical/anterior prolapse and concomitant severe posterior colpocele. This surgical approach, in addition to improving the anatomical results of these patients, is associated with a significant improvement in sexual and quality of life indexes.

Supervised Pelvic Floor Muscle Training Improves Sexual Function and Diminishes Sexual Distress in Women with Relapsing-Remitting Multiple Sclerosis: A Randomised Controlled Study.

This study investigates the impact of pelvic floor muscle training (PFMT) on sexual function and distress in women with multiple sclerosis (MS), a prevalent chronic nervous system disorder associated with sexual dysfunction. This study's primary aim was to assess the effectiveness of PFMT at improving sexual function and alleviating sexual distress in this population. In a randomised controlled trial, 82 women with MS were divided into two groups: Group A (41 women) underwent 12 weeks of PFMT, while Group B (41 women) served as a control group with no intervention. Both groups were assessed at the beginning and end of this study using the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised (FSDS-R). Statistical analysis, including Chi-square tests, was employed to compare the outcomes between the two groups, with a p-value of less than 0.05 considered significant. The results revealed no significant differences in baseline sexual function and distress between the groups. However, at the conclusion of the 12-week period, Group A exhibited statistically significant improvements in nearly all domains of FSFI and FSDS-R compared to Group B, except in the pain domain. This study concludes that PFMT can effectively enhance sexual function and reduce sexual distress in women suffering from MS. These findings underscore the potential of PFMT as a therapeutic intervention in managing sexual dysfunction associated with MS.

Minority stressors and psychological correlates of sexual distress among Black queer and heterosexual women

Many women experience distress related to their sexual functioning. In fact, sexual distress is often the first sign of sexual functioning disorders. Yet, little is known about Black women’s experiences of sexual distress. The purpose of this study is to explore the correlation between psychological factors (distress, post-traumatic stress disorder, perceived stress, and financial worry), minority stressors (superwoman schema and sexual objectification), and sexual distress among Black queer and heterosexual women. A cross-sectional survey was administered to 448 Black women aged 19–67, recruited via social media and snowball sampling. The data was analyzed using bivariate correlations to explore the differences between Black queer women and Black heterosexual women. The findings of this study showed significant differences in sexual distress scores between Black heterosexual and queer women. However, there were significant differences in which factors were correlated with sexual distress between these two groups. Implications for culturally responsive treatments for sexual distress are included.